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Evaluation of the effect of Dilapane-S gel on preoperative cervical preparation

Evaluation of the efficacy of dilapane-S gel in comparison with misoprostol during pre-hysteroscopic cervical preparation

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191123045476N2
Enrollment
120
Registered
2021-02-19
Start date
2020-09-22
Completion date
Unknown
Last updated
2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysteroscopy.

Interventions

Intervention 1: Intervention group: Patients in the intervention group undergoing placement with Dilapane S (3MM * 55MM) made by Kardan Elixir Company, 6 hours before hysteroscopy, which is first mois

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
49 Years to 52 Years

Inclusion criteria

Inclusion criteria: Postmenopausal women (at least 1 year after the last menstrual cycle) or Nolipar or Multipar who have no history of natural childbirth are candidates for hysteroscopic surgery due to uterine myoma and uterine polyp. Postmenopausal women (at least more than 1 year after the last menstrual cycle) or Nolie Par or Multipar who have no history of normal delivery are candidates for hysteroscopic surgery due to increased endometrial thickness confirmed by ultrasound or abnormal vaginal bleeding

Exclusion criteria

Exclusion criteria: Contraindications to hysteroscopy Recent or current pelvic infections Previous cervical surgery Confirmed cervical or breast malignancies Vaginal delivery history Hypersensitivity to misoprostol and prostaglandins

Design outcomes

Primary

MeasureTime frame
Cervical dilatation. Timepoint: The time required to start dilatation until the arrival of a hysteroscope or resectoscope will be recorded as a conclusion. Method of measurement: Initially, the initial condition of the cervix, including the position and softness of the cervix, will be evaluated observably. No resistance is passed as dilatation before hysteroscopy and will be recorded as a conclusion. Our ultimate goal will be dilatation with Hagar number 10-8.

Secondary

MeasureTime frame
Severe pain and bleeding after hysteroscopy. Timepoint: Immediately after the patient regains consciousness. Method of measurement: visual analog scale, which includes a table to evaluate the patient's pain and bleeding in the form of zero indicates painless and ten indicates severe and unbearable pain and bleeding.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamaneh Rokhgireh

Iran University of Medical Sciences

s.rokhgireh@gmail.com+98 21 6435 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026